Ranibizumab for Treating Submacular Vascularized Pigment Epithelial Detachments
United States40 participantsStarted 2008-09
Plain-language summary
This is a multicenter, randomized, open-label study. 40 patients will be followed for a period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg of intravitreal ranibizumab injection.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Patient is 50 years or older
* Patient is willing to participate in this study and to follow the criteria and protocol of this study.
* Patient is not involved with another clinical trial.
* Ability to understand the informed consent and willingness to sign the consent.
* Presence of a submacular vascularized or fibrovascular PED. Central foveal involvement by the PED or the CNV due to age related macular degeneration.
* PED less than or equal to 12 disc area in size
* BCVA with ETDRS of greater than or equal to 19 letters and less than or equal to 69 letters (20/400 to 20/40)
* Central 1-mm foveal thickness of greater than or equal to 250 microns on OCT.
* Greatest linear diameter of the submacular hemorrhage needs to be less than 50% of the entire PED.
* Submacular fibrosis needs to be less than 50% of the entire PED.
* Sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA, and FP.
* Intraocular pressure of 25 mm or less in the study eye, with or without use of ocular hypotensive agents.
Exclusion Criteria:
* Pregnancy or lactation
* Premenopausal women not using adequate contraception
* Known serious allergies to ranibizumab, fluorescein dye, drug for pupillary dilation, topical anesthetic, sterilizing solution
* Contraindication to pupillary dilation in study eye
* Any condition (including inability to read visual acuity charts or language barrier) that may preclude patient's ability to comply with the study protocol requā¦
What they're measuring
1
Mean change in Best Corrected Visual Acuity from baseline measured at 4 meters on the ETDRS chart at 12 months.